Thrombin Generation Assay
European Union Price €450,-
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Thrombin is a key enzyme of the coagulation cascade. Its measurement gives direct information about the thrombogenicity of a biomaterial (i.e., its ability to form blood clots). In normal plasma, thrombin is captured into the fibrin meshwork and is rapidly inactivated by antithrombin III or other antiproteases. The short half-life of thrombin hampers its accurate enzymatic determination. Therefore, HaemoScan has designed the Thrombin Generation Assay , which is based on a special plasma product that enables the determination of thrombin activity in an incubation medium after this has been exposed to a biomaterial. This method is suited to evaluate the haemocompatibility of biomaterials and medical devices according to the international standard ISO 10993-4:2002.
 W. van Oeveren, J. Haan, P. Lagerman, and P. Schoen, “Comparison of coagulation activity tests in vitro for selected biomaterials.,” Artificial organs, vol. 26, no. 6, pp. 506–11, Jun. 2002.
Measuring biomaterial induced thrombin generation. This kit is intended for laboratory research use only and is not for use in diagnostic or therapeutic procedures. The analysis should be performed by trained laboratory professionals.
The TGA gives an indication of the thrombogenicity of a biomaterial. The amount and speed of thrombin formation, when the biomaterial is incubated in modified plasma, is measured and compared to that of reference materials. Highly reactive and less-reactive reference materials are included in the kit, one type of metal and two types of polymers. It is recommended to include at least two reference materials in each analysis. Reference materials can be selected to compare with the activities of the test samples.
Materials are first incubated in plasma. After the TGA reagent has been added, the generation of thrombin will begin. At different time points the thrombin generation is measured. The concentration of thrombin is determined by enzymatic reaction with a thrombin-specific chromogenic substrate, which yields a yellow colored product proportional to the amount of thrombin.
The thrombin concentrations of the samples can be determined from a calibration curve. A thrombin generation curve for each material is constructed by plotting the thrombin concentrations versus the time points on which the samples were taken. This curve is used to determine the speed of thrombin generation, which is expressed per cm2 sample. The results of the tested materials in relation to the reference materials may be used to evaluate the thrombogenicity.
The kit is designed to determine thrombin-generating activity of small samples of biomaterial. Larger samples can also be used as long as the ratio between TGA plasma and material size is respected.
Storage and Stability
Product should be stored at -20 °C.
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